MXPA01005789A - Needleless syringe with prefilled cartridge - Google Patents

Abstract

A cartridge and nozzle assembly for use in a non-needle injection system is provided. The assembly includes a cartridge (12) having a plunger (24) disposed at a rearward end thereof including a throat (21) at a forward portion thereof with a displaceable outlet valve (46) initially disposed within the throat (21), the outlet valve (46) being formed of resilient material, having at least one axial channel (56, 62) defined in the forward, and rearward portion thereof, between which is disposed a non-channel valve body (58);a nozzle (14) for receiving the cartridge (12);the nozzle (14) defining a rearward cartridge receiving portion, and including a forward portion terminating in, and defining a valve abutment surface (48) with an injection orifice (52) defined therein;and a recessed portion (50), the recessed portion (50) being configured to receive the valve (46) when the valve (46) is displaced to a forwardly disposed position such that the valve (46) is disposed against the valve abutment surface (48) so that the inner portion of the cartridge (12) has fluid access to the orifice (52) via the axial channels (56, 62), and around the valve body (46);a seal (22) disposed between the cartridge (12), and the nozzle (14) adjacent the forward portions thereof for at least reducing leakage of injection therebetween.

Description

HANDLE WITHOUT NEEDLE WITH PRE-LENGTH CARTRIDGE BACKGROUND OF THE INVENTION This invention relates to a needleless injection system that includes a pre-filled cartridge. One of the problems inherently present in the packaging of parenteral, liquid drugs is that there is not enough biocompatibility data about the interaction between these drugs and the thermoplastic containers. While plastic is commonly used in many injection devices, most parenteral drugs can not be exposed to most plastics other than a short period immediately prior to injection. This is because the drug or the injectable product can react chemically with the plastic, or cause the materials in the plastic to leach into the injectable product, thereby introducing impurities into the drug. In periods of prolonged storage, this exposure to a plastic container may result in the degradation of the drug. For these reasons, the pharmaceutical industry normally avoids the storage of the injectable product in some thermoplastic materials such as polypropylene, which is commonly used in syringes and related injection accessories. Similarly, there are no long-term biocompatibility data for high-strength or engineering thermoplastics, such as polycarbonate, which is the most commonly used plastic in needle-less injection systems. For this reason, injectable products are typically stored in glass jars. Immediately prior to injection, the injectable product chamber of a needleless injection system is filled from a glass vial containing the drug. This usually requires the use of a bottle adapter, sometimes referred to as a blunt filling device, or an access needle that pierces the protective membrane over the top of the bottle and then directs the injectable product down to the chamber or cartridge of the needleless injection system. There are several disadvantages with this conventional approach. For example, the additional step of transferring the drug from the glass bottle to the needleless injection system is time consuming and can be problematic for a patient who is trying to administer the drug at home and who may have physical illnesses. Even for those who are not sick, an adapter must be handy and must be sterile to prevent contamination of the injectable product. The adapter typically includes a transfer needle with a sharp tip at one end to puncture the membrane of the vial, and which can lead to injury, to the non-proposed introduction of the injectable product into the operating personnel or administrator, and / or to the contamination of the injectable product. This additional step of filling the needleless injection system immediately prior to injection also results in the possibility of leakage and waste of the injectable product, and, if performed improperly, can introduce air into the injection system. The introduction of air presents difficulties in a needleless injection system, because different from a conventional syringe and needle system, it is not easy to remove it easily from the chamber of a needleless device. Therefore, driving the injectable system with a portion of its chamber filled with air results in a lower dose that is injected to the patient. It is also possible that the injection may take place at inappropriate pressure. An advantage of the needleless injection systems of Bioject, Inc., assignee of this patent, is that they are capable of accurately injecting a predetermined amount of the injectable product in a precise, predetermined location in the patient's tissue. The introduction of air can make it difficult to achieve this precision. Accordingly, it is an object of the present invention to provide pre-filling of a cartridge to be used in a needleless injection system.

BRIEF DESCRIPTION OF THE INVENTION A cartridge and nozzle assembly is provided for use in a needleless injection system. The assembly includes: (1) a cartridge having a plunger positioned at a rear end thereof, and including a throat at a front portion thereof, with a displaceable outlet valve initially positioned within the throat, the outlet valve which is formed of resilient material and having at least one axial channel defined in the front and rear portions thereof, between which a valve body without channel is placed; (2) a nozzle for receiving the cartridge, the nozzle defining a rear cartridge receiving portion, and including a front portion ending in, and defining a valve attachment surface with an injection orifice defined therein and a recessed portion, the recessed portion that is configured to receive the valve when the valve is placed in a forward position such that the valve is placed against the valve attachment surface, and so that the inner portion of the cartridge has access to the fluid to the orifice via the axial channels and around the valve body; and (3) a seal placed between the cartridge and the nozzle adjacent to the forward portions thereof to reduce at least the leakage of the injectable product therebetween. Another aspect of the invention provides a cartridge and nozzle assembly for use in a needleless injection system, comprised of the following components: (1) a cartridge having a plunger positioned at a rear end thereof, and including a throat in a forward position thereof; (2) a membrane placed through the throat of the cartridge that ruptures when a predetermined amount of pressure is applied to the fluid in the cartridge; and (3) a nozzle for receiving the cartridge, the nozzle defining a rear portion, for receiving the cartridge, and including a front portion that terminates in, and defines an injection orifice, with the inner portion of the cartridge having access to the fluid to the orifice when the membrane breaks. Yet another aspect of the invention is a method for providing a needleless injection for a patient. The method includes the following steps, not necessarily in the order mentioned: (1) selecting a resilient valve having a plurality of channels defined therein and a body portion positioned between the channels; (2) select a cartridge that has a front throat that fits the valve body; (3) place the valve inside the cartridge throat; (4) Fill the cartridge with the injectable product, liquid; (5) install a plunger at the rear end of the cartridge; (6) selecting a nozzle with a rear cartridge receiving portion and a front portion defining a depression to receive the valve in an unsealed manner and an opening to facilitate injection of the injectable product therethrough; (7) Install the cartridge in the nozzle to form a cartridge / nozzle assembly; and (8) mounting the cartridge / nozzle assembly in a needleless injection system by pushing the plunger back against a ram to move the plunger forward, causing the pressure of the injectable product within the cartridge to move the valve forward to the nozzle depression to allow the injectable product to flow around the body, through the channels, and toward the opening.

BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 is a sectional view, in lateral elevation of the pre-filled cartridge of the present invention, with its initial position before insertion of the cartridge shown in broken lines, and the inserted portion, before pressurization initial, shown in solid lines; Figure 2 is a sectional elevation view taken along the line 2-2 of Figure 1, showing the cartridge in its inserted position; Figure 3 is a sectional side elevational view showing the position of the cartridge and nozzle within a preferred embodiment of the needleless injection system; Figure 4 is a fragmentary, enlarged, sectional, side elevational view of the outlet valve and adjacent portions of the cartridge / nozzle assembly of the embodiment of Figure 1, with the outlet valve shown in its non-pressurized position; Figure 5 is a view corresponding to Figure 4 except that the outlet valve is shown in section and is changed to its forward position; Figure 6 is an enlarged, lateral, enlarged view of the outlet valve of the embodiment of Figure 1; Figure 7 is a sectional elevation view taken along the line 7-7 of Figure 6; Figure 8 is a sectional view, in terminal elevation taken along line 8-8 of Figure 6 showing the forward portion of the outlet valve; Figure 9 is a sectional elevation view taken along the line 9-9 of Figure 4 showing the rear portion of the outlet valve; Figure 10 is an isometric view of the outlet valve of Figures 1-9. Figure 11 is a sectional view in side elevation of an alternative embodiment showing a membrane in the place of the outlet valve; Figure 12A is a side elevation view of the embodiment of Figure 11, with the membrane broken; Figure 12B is an isometric view corresponding to Figure 12A; Figure 13A is a sectional elevation view of a second alternative embodiment, with the outlet valve in its closed position; Figure 13B is a view corresponding to Figure 13A except that the outlet valve is shown in its forward position; Figure 14A is an isometric view of an outlet valve corresponding to the outlet valve shown in Figures 13A and B except that the valve fins have notches to facilitate tearing when pressure is exerted on the valve; Figure 14B is a view corresponding to Figure 13A except that the notched fin version of the outlet valve, shown in Figure 14A, is shown; Figure 14C corresponds to Figure 14B except that the outlet valve is shown in its open position; Figure 15 is a fragmentary, side elevation, sectional view of yet another alterative embodiment of the nozzle without the cartridge or outlet valve, showing the ribs in the nozzle depression; Figure 16A is an enlarged, side elevational sectional view of the embodiment of Figure 15, showing the cartridge and the outlet valve in its closed position; Figure 16B is a view corresponding to Figure 16A except that the outlet valve is shown in its forward position. Figure 17A is a sectional elevation view of another alternative embodiment, with the cartridge in a position partially inserted in the nozzle; and Figure 17B is a sectional side elevational view of the embodiment of Figure 17A except that the cartridge is shown in its fully inserted position.

DETAILED DESCRIPTION OF THE PREFERRED MODALITIES The embodiment of Figures 1-10 In Figures 1-10 a form that the invention can take is represented. This description will initially refer to these figures.

Represented generally at 10 is a cartridge / nozzle assembly in which the cartridge can be pre-filled with liquid injectable product. The assembly includes a cartridge 12 which, in the preferred embodiment, is formed of reinforced glass, and a nozzle 14, which, in the preferred embodiment, is made of high strength thermoplastic, typically polycarbonate. The nozzle 14 is of conventional design except that the rear (or left) portion in Figure 1 includes a plurality of tabs 16 uniformly spaced apart. In the embodiment shown, four of these tabs are included, placed at 90 degree intervals around the nozzle, two of which are shown in dashed lines in Figure 1. Alternatively, three or even two of these can be used. tabs With the cartridge 12 placed in its partially inserted position shown in dashed lines in Figure 1, the tabs 16 can be displaced radially outward and are retained by the walls 18 of the cartridge. It is easy to insert the cartridge 12 in this partially installed position because the walls 18 of the cartridge taper at 20 at the front end thereof. The tapered walls 20 thus define an inner throat 21 positioned at the front end of the cartridge 12. An O-ring 22 is typically positioned adjacent this tapered, forward end of the cartridge 12 between the cartridge and the nozzle 14. A ring is included. step 28 on the inner surface of the side walls 30 of the nozzle 14, to provide a stop and a sealing surface for the O-ring 22 placed between the leisurely portion 20 of the cartridge walls 18 and the interior surface of the walls 30 side of the nozzle. The O-ring thus prevents the flow of the injectable product along the face between the outer surface of the walls 18 of the cartridge and the inner surface of the side walls 30 of the nozzle. A plunger 24 is placed within the walls 18 of the cartridge 12, and controls the injection of the injectable product out of the cartridge, as desired by the operator. At the factory, or at a user's location, the cartridge 12 is inserted into the nozzle 14, as shown in Figure 1 and then pressed forward and completely towards the nozzle, as shown in solid lines in Figure 1 , causes the tapered portion 20 of the walls 18 of the cartridge 12 to butt to a cartridge attachment surface 26 at the forward end of the nozzle 14.

An advantage of the present invention is that it allows the cartridge 12 to be pre-filled with injectable product and then stored in a suitable location, be it that which is in the factory, in a hospital or other medical facility, a pharmacy, in an ambulance, or in the residence of a patient who may need the medication. Alternatively, the cartridge 12 can be filled and stored in its position within the nozzle 14, ready to be inserted into a needleless injector, such as that shown generally at 32 in Figure 3. The needleless injector 32 with which cartridge / nozzle assembly 10 is typically used, is shown in U.S. Patent No. 5,399,163 to Peterson et al., although assembly 10 can be used in a wide variety of other needleless injection systems. Patient '163 by Peterson is incorporated herein by reference. As shown in Figure 3, the cartridge / nozzle assembly 10 is mounted to the front end 34 of the injector 32 by a series of uniformly spaced handles 36, three of which are typically placed 120 degree intervals around the periphery of the nozzle 14. The handles 36 on the nozzle 14 align to pass through the corresponding spaces 38 placed in the front end 34 of the injector 32. The cartridge / nozzle assembly 10 is then rotated to secure it in its position such that the lugs 36 are placed between the inner surface 40 of the front end 34 of the injector 32 and a grip-joining surface 42 in the injector 32. As the cartridge and nozzle assembly 10 is inserted into the injector 32, the front end of a ram 44 is butted to a teflon pad 45, somewhat resilient mounted on the rear end of the plunger 24. The contact between the ram 44, pad 45 and the plunger 24 is made before the lugs 36 reach the grip-joining surface 42, in the injector 32. As the cartridge 12 continues to be pushed towards the injector 32, with the handles 36 positioned against the handle-joining surface 42, the ram 44, which is stationary, will cause that the plunger 24 slides forward, which will consequently cause the liquid injectable product within the cartridge 12 to move towards the outlet valve 46, allowing the flow of liquid to a recessed portion 50 and towards the jet orifice 52 (FIG. see Figure 1). The amount of liquid flowing through the outlet valve 46 during insertion of the cartridge 12 into the injector 32 is controlled by the length of the ram 44 relative to the interior surface 40. As best shown in Figure 4, it places an outlet valve 46 adjacent to the inner surface of the tapered walls 21 and at the front end of the cartridge 12. This valve 46 is typically manufactured from butyl rubber or other resilient material which is a suitable drug storage material and is capable of being sterilized prior to insertion into the cartridge 12. As shown in Figure 4, the valve 46 is designed to fit tightly within the forward end of the cartridge 12. As best shown in Figures 6-10, the intermediate portion or body 58 of the outlet valve 46 is normally of a round cross section, and is made to be of a size such that it fits comfortably within the tapered walls 20 of the art. 12. The back portion of the outlet valve 46 includes a plurality of slots 56 (here, four) that extend rearwardly from a body portion 58 centrally positioned in the outlet valve 46. The forward end 51 of the outlet valve 46 includes forwardly extending members 62, which extend axially from the body 58 of the outlet valve 46 to define two perpendicular valve channels 64. In the preferred embodiment, the outer diameter of the outlet valve is slightly larger than the inner diameter of the tapered walls 21, with the outlet diameter of the outlet valve typically being 0.105 inches, and the inside diameter of the walls tapered which is 0.098 inches. This difference in sizing, together with some elastic properties of the butyl rubber or other material from which the outlet valve 46 is formed, allows a frictional fit at the front end of the cartridge 12. However, once pressure is exerted hydraulic in the outlet valve 46, such as when the cartridge / nozzle assembly 10 is pushed into place in the needle-less injector 32 while the ram 44 is held stationary within the injector, the outlet valve 46 is forced to an initially pressurized forward position, shown in Figure 5, with the forward end of the outlet valve 46 positioned against the valve attachment surface 48 at the forward end of the recessed portion 50 of the forward end of the nozzle 14. This surface 48 butt joint typically includes a surface or shoulder extending in a direction perpendicular to the longitudinal dimension of the nozzle 14 and to the direction n displacement of the outlet valve 46. The forward end 51 of the outlet valve 46 typically includes a surface that complements that of the shoulder of the abutting surface, which also extends perpendicular to the longitudinal dimension of the valve and to the direction of travel of the valve. The front end of the hollow portion 50 ends in a jet orifice 52 having a nozzle orifice channel 54, generally conical in shape. The relative sizing of the outlet valve 46, respectively, the inner surface of the tapered walls 20 and the recessed portion 50 such that the fluid is allowed to flow from the cartridge and into the recessed portion surrounding the outlet valve and perhaps still out of the injection opening 52.

Operation of the embodiment of Figures 1-10 In the operation, at the factory or at the user's location, the cartridge 12 is inserted into the nozzle 14 as shown in dashed lines in Figure 1 and then pressed forward and completely towards the nozzle, as shown in solid lines in Figure 1 until the tapered portion 20 of the walls 18 of the cartridge 12 buttly engage with the cartridge attachment surface 26 at the forward end of the nozzle 14. Before of assembling the cartridge / nozzle assembly 10 within the injector 32, as shown in Figures 1 and 4, the outlet valve 46 is received in the throat 21 of the cartridge 12 in its pre-initial pressure position. When the valve is in this position, the fluid placed inside the cartridge is prevented from flowing out of the throat 21 by the body portion 58 of the valve 46. Because the ram 44 in the injector 32 is held stationary, according to the cartridge / nozzle assembly 10 is inserted into an injector 32, the pressure of the plunger 24 against the fluid placed in the cartridge 12 causes the outlet valve 46 to move towards its initially pressurized, forward position shown in Figure 5. Due When the outlet valve 46 includes slots 56, fluid within the cartridge is allowed to flow through the cartridge throat 21 and into the recessed cartridge portion 50. The front valve channels 64 in the outlet valve 46 allow the fluid to precipitate to the recessed portion 50 to displace any air in the recessed portion, forcing that air out of the orifice channel 54 and the orifice 52, so that the recessed portion, the orifice channel and the opening will be completely filled with the injectable product. This can also result in some of the injectable product coming out of the jet orifice, but because it is an insignificant amount, it is of little interest. What is important is that all the air travels in front of the nozzle 14. This allows the amount of injectable product to be injected into the patient to be accurately measured, which would not be possible if an unknown amount of air were placed in the patient. the front of the mouthpiece. This also allows the pressure to be precisely predetermined, again, which would not be possible if an indeterminate amount of air were placed in the front of the nozzle. This insertion step of the cartridge / nozzle assembly 10 in the injector 32 is typically performed immediately prior to injection. In this way, with the assembly 10 in place, the needleless injector 32 can be activated, forcing the ram 44 and the plunger 24 forward, thereby driving the injectable product through the slots 56 in the valve 46 of outlet, around the body 58 positioned within the recessed portion 50, through the valve channels 64 and in the opening channel 54 and the opening 52 and up to the patient. Due to the configuration of the outlet valve 46, the throat 21 and the inner walls of the recessed portion 50, there is very little pressure drop as the fluid is forced out of the cartridge and out of the injection opening 52.

The embodiments of Figures 11, 12A and 12B Figures 11, 12A and 12B represent an alternative embodiment of the pre-filled cartridge / nozzle assembly, indicated generally at 110. Instead of an outlet valve, the 110 embodiment includes a elastomeric membrane 166 which is designed to open when a predetermined pressure has been applied, as shown in Figures 12A and 12B. The membrane 166 normally has a weakened portion next to which the break will occur. In the embodiment shown, this weakness portion takes the form of a notch 167 that extends, at most, but not completely around 360 ° into the inner throat 121 of the cartridge 112. The membrane 166 is typically held in place by an aluminum seal 168 that is frequently used to help seal cartridges containing medicine. In other aspects, mode 110 is very similar to mode 10 in that it includes O-rings 122 and nozzle 114, and is typically filled with injectable product. The membrane 166 is designed to open when loaded in a needleless injector system as the plunger (not shown) is slightly pressed by the injector ram (not shown) as explained above. Upon rupture of the membrane 166, the injectable product flows into the depression 155 at the forward end of the nozzle 114, thereby displacing any air by preparing the assembly for an injection.

The embodiment of Figures 13A and 13B Figures 213A and 13B depict another alternative embodiment of the cartridge / nozzle assembly, generally indicated at 210. This embodiment uses an aluminum seal 268 as does the 110 mode, but also includes a valve 246. of exit. The outlet valve 246 includes a pair of radially extending fins 270 that are secured under the aluminum seal 268 until a predetermined amount of pressure forces the outlet valve 246 out of the inner throat 221 of the cartridge 212. When this predetermined pressure is reached, the fins 270 push out of the seal 268 and the valve moves forward towards the recessed portion 250 of the nozzle 214 until it is in contact with the nozzle attachment surface 248. Unlike the presence of the fins 270, the outlet valve 246 is the same as the outlet valve 46 previously described in the cartridge / nozzle assembly 10 of Figures 1-10. In this way, when the outlet valve 246 is moved to its forward position shown in Figure 13B, the injectable product is allowed to flow out of the cartridge 212 and into the recessed portion 250 to displace any air and thus prepare the assembly 10 for an injection, as described above.

The embodiment of Figures 14A-C The cartridge / nozzle assembly 310 of Figures 14A-C is identical to assembly 210 except that the fins 370 of the outlet valve 346 includes weakened portions. In the embodiment shown, these weakened portions take the form of a pair of notches 372. In this way, when the cartridge / nozzle assembly 310 is mounted in a no-shot injection system (not shown), instead of flaps 310 are pushed out of engagement with the seal 368, the flaps typically tear in the notches 372 to allow the outlet valve 346 to move to the forward position shown in Figure 14C. In other aspects, the operation of the cartridge / nozzle assembly 310 is the same as the assemblies 10 and 210 described above.

The embodiment of Figures 15, 16A and 16B. The cartridge / nozzle assembly 410 of Figures 15, 16A and 16B is identical to the assembly 10 in Figures 1-10 except that the recessed portion 450 of the nozzle 414 includes a plurality of recesses. 474 ribs evenly spaced. In the embodiment shown, four of these ribs 474 are included. First they extend along the walls of the recessed portion 450 in a direction parallel to the travel path of the outlet valve 446, and then extend radially along the abutting surface 448. The portions extending along the walls of the recessed portion 450 are made of a size such that the outlet valve 446 fits snugly in the recessed portion, as shown in Figure 16B, with the inside diameter of the space defined between the ribs 474 which is slightly smaller than the inner diameter of the cartridge groove 421. This slight difference in the internal diameters prevents the outlet valve 446 from moving inadvertently forward during the thermal changes and the minor pressure changes resulting therefrom. The relative sizing of these internal diameters allows the opening pressure of the outlet valve to be controlled. Channels 476 are thus defined between ribs 474 to allow fluid to flow around outlet valve 446 to port 52. Because fluid flow is also facilitated, this is actually the most preferred embodiment of the invention . In other aspects, cartridge / nozzle assembly 410 is constructed and operated in the same manner as assembly 10 of Figures 1-10.

The embodiment of Figures 17A and B Figures 17A and B represent another alternative embodiment of the cartridge / nozzle assembly shown generally at 510. The assembly includes a cartridge 512 and a nozzle 514. The cartridge 512 is filled with injectable product as described in FIG. represents above and is sealed with an aluminum seal 568 and an elastomeric membrane 566, normally made of butyl rubber. A prong 578 is provided to pierce the membrane 566 when the cartridge is fully inserted into its position in the mouthpiece, as shown in Figure 17B. The prong includes an internal channel 580 which is in fluid contact with the orifice 552. An O-ring seal 522 is provided to prevent leakage between the cartridge and the nozzle. In this way, in use, the cartridge 512 is placed inside the nozzle 514 at a position such that the tine 578 reaches, but does not pierce the membrane 566. Then, immediately before the injection the cartridge 512 is pulled completely in the nozzle 514, causing the prong 578 to pierce the membrane 566 so that the injectable product is allowed to flow through the channel 580 of the prong to the orifice 522 to displace any air in the channel. The orifice is then placed against the skin of the patient and the injector (not shown) is activated, causing the injectable product to be forced out of the cartridge 512, in the tine 578, through the tine channel 580 and the hole 552 and up the patient. In other aspects, the cartridge / nozzle assembly 510 is the same in structure and operation as the previously described modes. Other changes and modifications of the present invention can be made without departing from the spirit and scope of the present invention. These changes and modifications are proposed to be covered by the following claims.

Claims (18)

1. CLAIMS 1. A cartridge and nozzle assembly for use in a needleless injection system, comprising: a cartridge having a plunger positioned at a rear end thereof, and including a throat at a front portion thereof, the cartridge that additionally includes a skin surface extending generally laterally; a displaceable outlet valve initially positioned within the throat of the cartridge, the outlet valve being formed of resilient material; a nozzle for receiving the cartridge, the nozzle defining a rear cartridge receiving portion, and including a front portion terminating in, and defining a valve attachment surface with an injection orifice defined therein, - front portion that is configured to receive the valve when the valve is moved to a forward position such that the valve is positioned against the valve attachment surface, with a plurality of channels being defined between the surface of a valve and the valve, the channels that provide access to the fluid between the throat of the cartridge and the injection orifice when the valve is in its forward position, the nozzle further including a generally laterally extending interface surface, which joins the cartridge interface surface; and a seal placed between the cartridge and the nozzle backward of the inter face surfaces to at least reduce leakage of the injectable product therebetween. The assembly according to claim 1, wherein the cartridge groove tapers and the seal is mounted at a defined distance between the cartridge and the nozzle, adjacent to the throat of the cartridge. The assembly according to claim 1, wherein the valve attachment surface includes a shoulder extending perpendicular to the travel path of the valve, and the valve includes a complementary surface that also extends perpendicular to the travel path from valvule. The assembly according to claim 1, wherein the rear portion of the outlet valve extends at least partially in the cartridge throat when the forward portion thereof is displaced against the abutting surface. The assembly according to claim 1, wherein the cartridge includes a peripheral seal placed on at least a portion of the outlet valve to hold the outlet valve in place to hold the cartridge closed and sealed until it is pressurized in a manner enough the cartridge. The assembly of claim 5, wherein the outlet valve includes a portion extending radially adjacent to the front portion thereof, at least a portion of the radially extending portion that is covered by the peripheral seal when the outlet valve is in its closed position. The assembly according to claim 6, wherein the radially extending portion includes a weakened portion positioned radially inwardly of the peripheral seal that is subjected to tearing to allow the outlet valve to move forward to open the cartridge. The assembly according to claim 1, wherein the cartridge is formed of glass. 9. A cartridge and nozzle assembly for use in a needleless injection system, comprising: a cartridge having a plunger positioned at a rear end thereof, and including a throat in a forward portion thereof; an outlet valve initially positioned within the throat of the cartridge, but which can be displaced relative to the cartridge along a forwardly extending valve travel path, the outlet valve being formed of resilient material and having at least one axial channel defined in a rear portion thereof, a portion of the outlet valve positioned forward of the rear portion including a valve body without channel; and a nozzle for receiving the cartridge, the nozzle forming a rear cartridge receiving portion, and including a front portion having walls defining a recessed portion with an injection orifice defined therein, the recessed portion having a plurality of ribs, at least a portion of the ribs extending perpendicular to the travel path of the valve, the ribs forming a valve attachment surface in the recessed portion so that when the valve travels to a further positioned position the valve is in contact with the valve attachment surface to provide fluid access from the inner portion of the cartridge to the nozzle orifice via the axial valve channel, around the valve body, and between the ribs. The assembly according to claim 9, wherein the other portion of the ribs extends along the walls of the recessed portion in a direction parallel to the travel path of the valve and defining a valve receptacle, which it has a smaller diameter than the throat of the cartridge so that a minimum fluid pressure is required, established to move the valve from the cartridge throat to the valve receptacle. The assembly according to claim 9, wherein the rear portion of the outlet valve extends at least partially to the cartridge throat when the valve is in its most forward position. The assembly according to claim 9, wherein the cartridge is formed of glass. 13. A cartridge and nozzle assembly for use in a needleless injection system, comprising: a cartridge having a plunger positioned at a rear end thereof, and including a throat at a front portion thereof; a membrane placed through the cartridge throat that ruptures when a predetermined amount of pressure is applied to the fluid in the cartridge; and a nozzle for receiving the cartridge, the nozzle defining a rear cartridge receiving portion and including a front portion terminating in, and defining an injection orifice, with the inner cartridge portion having fluid access to the orifice when the membrane breaks The assembly according to claim 13, further comprising a seal placed between the cartridge and the nozzle to reduce at least the leakage between them. The assembly according to claim 13, wherein the membrane is elastomeric and includes a weakened portion. 16. A method for providing a needleless injection system, comprising: selecting a resilient valve member; selecting a cartridge having lateral sidewalls, a front throat that fits the valve body; place the valve inside the cartridge throat; fill the cartridge with the injectable product, liquid; install a plunger at the rear end of the cartridge; selecting a nozzle with side walls that sideways, a rear cartridge receiving portion and a front portion having a depression for unsealed receiving of the valve such that a plurality of channels are defined between the valve and the nozzle, the nozzle which additionally includes a hole to facilitate the injection of the injectable product therethrough; select a cartridge / nozzle seal member; installing the cartridge in the nozzle to form a cartridge / nozzle assembly, with the seal member positioned between the cartridge side walls and the nozzle; and mounting the cartridge / nozzle assembly in a needleless injection system by pushing the plunger back against a ram to move the plunger forward, causing the pressure of the injectable product within the cartridge to move the valve forward in the depression of the cartridge. nozzle to allow the injectable product to flow through the channels, and towards the hole. The method according to claim 16, further comprising: subsequently making the injection pressure exerted by the ram on the plunger force the injectable product from the cartridge, through the channels and through the opening and towards the patient. The method according to claim 16, wherein the step of selecting the valve comprises selecting the valve having a surface extending radially outwardly with a tear-off portion defined therein, and wherein the step of pushing the plunger and causing the pressure to move forward the valve comprises tearing the tear-off portion and thus allowing the valve to move forward. 18. A cartridge and nozzle assembly for use in a needleless injection system, comprising: a cartridge having a plunger positioned at a rear end thereof, and including a throat in a front portion thereof; a membrane placed through the cartridge throat; a nozzle for receiving the cartridge, the nozzle defining a rear cartridge receiving portion and including a front portion terminating and defining an injection orifice, the nozzle further including a rearwardly extending barb defining a channel which extends therethrough in fluid contact with the orifice positioned such that when the cartridge is fully inserted in the nozzle and the tine penetrates the membrane to allow fluid to flow through the cartridge, through the channel of the Barb and towards the mouth of the mouthpiece. The assembly according to claim 18, further comprising a seal placed between the nozzle and the cartridge to prevent the flow of fluid therebetween. 21. A needleless injection method, comprising: selecting a cartridge having a throat with a membrane extending in a sealable manner therethrough; fill the cartridge with injectable product, liquid; install a plunger at the rear end of the cartridge; selecting a nozzle with a rear cartridge receiving portion, a front portion defining a hole to facilitate injection of the injectable product therethrough, the nozzle further including a rearwardly extending barb having a channel therein. in contact for fluids with the hole; place the filled cartridge, the throat first, in the rear cartridge receiving portion of the nozzle and push the cartridge forward until the tine reaches but does not puncture the membrane; and pushing the cartridge completely into the nozzle, causing the prick to pierce the membrane, thereby allowing the injectable product to flow from the cartridge, through the cartridge throat, the tine of the mouthpiece and into the hole. The method according to claim 21, further comprising the steps of placing the hole against the skin of the patient, then exerting injection pressure on the cartridge plunger to inject the injectable product under pressure through the hole and towards the patient. The assembly according to claim 1, wherein the valve is made of a size to adjust its propulsion within the throat of the cartridge, and the valve includes a valve body without channel adapted to fit against the throat of the cartridge when the valve it is in its initial position. 24. The assembly according to claim 23, wherein the seal is positioned rearward of the initial position of the valve body. The assembly according to claim 1, wherein the cartridge throat includes a trailing end and the seal is positioned in alignment with the trailing end of the cartridge throat. The assembly according to claim 1, wherein the outlet valve has a valve body without channel so that the throat is sealed when the valve is placed inside the throat. 27. An assembly according to claim 1, wherein the plurality of channels are formed in the outlet valve. The assembly according to claim 1, wherein the inter face surface of the cartridge is generally facing forward, and the inter face surface of the mouthpiece is generally facing backward. 29. A cartridge and nozzle assembly for use in a needleless injection system, comprising: a cartridge having a plunger positioned at a rear end thereof, and including a throat in a front portion thereof, with a displaceable outlet valve initially positioned within the throat, the cartridge further including a surface that faces generally out; a nozzle for receiving the cartridge, the nozzle defining a rear cartridge receiving portion and including a front portion terminating in and defining a valve attachment surface with an injection orifice defined therein, the front portion that is configured to receive the valve when the valve is moved to a forward position such that the valve is positioned against the valve attachment surface, the nozzle further including a generally inwardly engaging surface the surface of the cartridge; and a seal placed between the outward facing surface of the cartridge and the inwardly facing surface of the nozzle to at least reduce leakage of the injectable product therebetween. 30. The assembly according to claim 29, wherein the seal includes a valve body without a channel and the seal is positioned rearwardly of the valve body. SUMMARY OF THE INVENTION A cartridge and nozzle assembly is provided for use in a needleless injection system. The assembly includes: (1) a cartridge having a plunger positioned at a rear end thereof, and including a throat at a front portion thereof, with a displaceable outlet valve initially positioned within the throat, the outlet valve which is formed of the resilient material and which has at least one axial channel defined in the front and rear portions thereof, between which a valve body without channel is placed; (2) a nozzle for receiving the cartridge, and the nozzle defining a rear cartridge receiving portion, and including a front portion ending in, and defining a surface in a valve with an injection orifice defined therein and a recessed portion, the hollow portion that is configured to receive the valve when the valve is moved to a forward position such that the valve is positioned against the valve attachment surface, and so that the inner portion of the cartridge has access to fluid to the orifice via the axial channels and around the valve body; and (3) a seal placed between the cartridge and the nozzle adjacent to the forward portions thereof to reduce at least the leakage of the injectable product therebetween.